Download - Invivo Investor Presentation
Symbol: NVIV
Investor Presentation 2012
Symbol: NVIV.OB
Symbol: NVIV
Safe Harbor Statement
This presentation contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward- looking statement can be guaranteed and actual results may differ materially from those projected. InVivo Therapeutics undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect InVivo's business, particularly those mentioned in the risk factors and cautionary statements in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements represent management's current expectations and are inherently uncertain. We do not undertake any obligation to update forward-looking statements made by us.
Symbol: NVIV
Introduction
• Founded in 2005
• Headquartered in Cambridge, MA
Developer of polymer-based medical devices for the
repair of spinal cord tissue
• Currently no successful treatment options for SCI patients
• Developing first and only treatments to address the underlying pathology of SCI
Platform technologies represent groundbreaking approach to the treatment of spinal cord injuries (SCI)
• Pursuing near-term launch of human pilot study,
• Will create new paradigm of care, addressing both acute and chronic injury
• $10+ billion global market potential for acute SCI alone
3 phase development strategy focused on speed to
market and expansion of products and application
• Partnerships with M.I.T., Harvard Medical School, Children’s Hospital Boston, Geisinger Health System, New England Baptist Hospital
Key scientific and medical community backing
Symbol: NVIV
http://www.cordtalk.org/
C6 - C7 Injury
Defeating Secondary Injury
Primary Acute Injury
Bleeding Inflammation Scarring Secondary
Injury
~ 21 Day Process
Loss of Motor Control & Sensory Function
[An animation shows the advancement of secondary injury in an open wound spinal cord injury from a penetrating injury such as a bullet wound. Results in scar tissue formation.]
[An animation shows the advancement of secondary injury in a closed wound spinal cord injury from a contusion such as a car accident. Results in scar tissue formation.]
Symbol: NVIV
Leadership Team
Frank Reynolds Chairman and CEO
Co-Founder
George Nolen Former President and CEO
of Siemens, Board of Directors, Lead
Director
Richard Roberts, PhD 1993 Nobel Laureate
Medicine & Physiology Board of Directors
Scientific Advisory Board
Eric Woodard, MD Chief Medical Officer
Scientific Advisory Board
Christi Pedra Sr. VP, Marketing
Cardinal Health USA Board of Directors
V. Reggie Edgerton, PhD Scientific Advisory Board
Todd Albert, MD Scientific Advisory Board
Jonathan Slotkin, MD Medical Director
Scientific Advisory Board
Rick Layer, PhD Manager
Research & Development
David Feigal Former Head of FDA Center for
Devices & Biologics Business Advisory Board
Dr. Robert Langer, ScD Co-Founder
Scientific Advisory Board
Adam Stern Sr. Managing
Director, Spencer Trask
Ventures.
Ed Wirth, Ph.D., MD Chief Science Officer
Scientific Advisory Board
Symbol: NVIV
Regulatory Submission Timeline
2011 2012 2013 2014 2015
Anticipated Submission Year
PLGA-PLL Scaffold
Injectable Hydrogel with drugs
PLGA-PLL Scaffold with cells
PLGA-PLL Scaffold with cells and drugs
Injectable Hydrogel with cells
Injectable Hydrogel with cells and drugs
Acute & Chronic SCI Peripheral Nerve Injury
Acute SCI Peripheral Nerve Injury
Peripheral Nerve Chronic Pain: Q2 ‘12
Acute SCI: July ‘11
Acute & Chronic SCI Peripheral Nerve Injury
Injectable Hydrogel with drugs Acute SCI Q3 ‘12
Acute & Chronic SCI
Symbol: NVIV
Support neuroplasticity: Spare 10% of spinal cord tissue to allow patients to recover function → Intervene before secondary injury causes permanent paralysis (therapeutic window)
Objective of Intervention
[An animation shows the current standard of care for an open wound injury to decompress and stabilize the spinal cord. No intervention to the spinal cord itself is performed and the spinal cord tissue become scar tissue. Animation then shows InVivo’s procedure to implant a scaffold into the open wound to prevent the spinal cord tissue from dying.]
[An animation shows the current standard of care for a closed wound or contusion injury to decompress and stabilize the spinal cord. No intervention to the spinal cord itself is performed and the spinal cord tissue become scar tissue. Animation then shows InVivo’s procedure to implant a scaffold using a Touhy needle injected into a closed wound to prevent the cord tissue from dying.]
Symbol: NVIV
Device Customization
[Device customization and implantation is completed in one minute and four seconds. Video from pilot non-human primate study shows Dr. Eric Woodard, Chief Medical Officer, customizing the scaffold in the operating room with a scalpel. The scaffold is then implanted into the spinal cord of an African Green Monkey (AGM). Approximately fifteen seconds after implantation the scaffold is shown absorbing the fluid inside the cord and changing color to match the surrounding tissue. Demonstrates the ability of the device to absorb fluids in the spinal cord.]
Symbol: NVIV
Injectable Surgical Intervention
[An animation shows the short procedure during which InVivo’s injectable hydrogel is guided by x-ray to, and injected into, the injury site. This technology provides a minimally invasive alternative to the scaffold and will be well suited for patients with additional injuries such as collapsed lungs or brain injuries. The hydrogel has been designed to time-release drugs based on the advancement of inflammation to mitigate inflammatory response.]
Symbol: NVIV
Implanting Scaffolds in Non-Human Primates
[Video shows Dr. Eric Woodard, Chief Medical Officer, and Dr. Jonathan Slotkin, Medical Director, during surgical implantation of InVivo’s scaffold into the spinal cord of an AGM.] [Figure (a) shows the scaffold design. Figure (b) shows stem cells attached to the scaffold under electron microscope. Figure (c) shows a higher magnification. Figure (d) shows the channels running through the scaffold allowing healthy tissue to be bridged. Figure (e) depicts the Brown-Sequard injury model resulting from the removal of 50% of the cord.]
Symbol: NVIV
Scaffold w hNSC Y430
Pilot Study: AGM Stem Cell Day 2
[This technology intended for chronic SCI patients. Video shows AGM two days post injury and treatment. This animal received a scaffold implanted with human neural stem cells after 50% of tissue was removed from a section of the spinal cord. There is no evidence of functional recovery as the monkey moves around in an ambulation chamber.]
Symbol: NVIV
Scaffold w hNSC Y430
Pilot Study: AGM Stem Cell Week 5
[Video shows the same AGM five weeks after receiving a scaffold with human neural stem cells. The AGM is walking with its spinal column parallel to the floor. This study was the first successful non-human primate study for traumatic SCI. Five different treatment arms have shown a therapeutic effect including the scaffold no drugs or cells, the scaffold with growth factors, the scaffold with low dose human neural stem cells, the scaffold with high dose human neural stem cells, and an injectable hydrogel with steroids.]
Symbol: NVIV
Control Scaffold w No Drugs/Cells
Pilot Study: AGM Scaffold Day 2
[Video shows AGM two days post injury where the animal received no treatment after 50% of the tissue from a section of the spinal cord was removed. The animal demonstrates Brown-Sequard syndrome; the left leg has no function, and the right leg functions properly.]
[First product to market. Video shows AGM two days post injury where the animal received InVivo’s scaffold without drugs or cells after 50% of the tissue from a section of the spinal cord was removed. The animal also demonstrates Brown-Sequard syndrome. The two animals appear to function similarly.
Symbol: NVIV
Control Scaffold w No Drugs/Cells
Pilot Study: AGM Scaffold Week 2
[Video shows AGM two weeks post injury where the animal received no treatment after 50% of the tissue from a section of the spinal cord was removed. The animal demonstrates Brown-Sequard syndrome; the left leg has no function, and the right leg functions properly.]
[Video shows AGM two weeks post injury where the animal received InVivo’s scaffold without drugs or cells. The animal runs and the previously paralyzed left leg has regained function.]
Symbol: NVIV
R123 Control R090 Scaffold
2nd Primate Study: AGM Week 12
[Video shows AGM twelve weeks post injury (received no treatment after 50% of the tissue from a section of the spinal cord was removed). The animal demonstrates Brown-Sequard syndrome; the left leg has no function, and the right leg functions properly.]
[Video shows AGM twelve weeks post injury (received the scaffold without drugs or cells after 50% of the tissue from a section of the spinal cord was removed). Wireless EMG and Kinematic technologies were added to the second study protocol to monitor electrical activity in the muscles in the legs of the animals. The animal runs on a treadmill demonstrating the left leg has regained function.]
Symbol: NVIV
R123 Control X957 Hydrogel
2nd Primate Study: AGM Week 12
[Video shows AGM 12 slides twelve weeks post injury (received no treatment after 50% of the spinal cord was removed). The animal demonstrates Brown-Sequard syndrome; the left leg has no function, and the right leg functions properly.]
[Video shows AGM twelve weeks post injury (received the injectable hydrogel technology after 50% of the tissue from a section of the spinal cord was removed). Wireless EMG and Kinematic technologies were added to the second study protocol to monitor electrical activity in the muscles in the legs of the animals. The animal runs on a treadmill demonstrating the left leg has regained function.]
Symbol: NVIV
EMG Analysis
[Split screen video shows AGM running on a treadmill on the left, and wireless EMG data being processed on the right. The data is synchronized with the animal running. Dr. Gregorie Courtine of the University of Zurich is responsible for processing EMG and kinematic data for InVivo and will present it to the FDA on the company’s behalf. Dr. Courtine has published a definitive paper in Nature on the value of non-human primate data in advancing rodent data to humans.]
Symbol: NVIV
GFAP (red) and neurofilament (green) immunoreactivity in cross-sections of Macaca Mulatta monkey
spinal cords near lesion center following hemi-section surgical injuries. Cell nuclei labeled with DAPI (blue).
A) Extensive astrogliosis (red) throughout the tissue near the midline in a control primate. The central canal was preserved (blue).
B) Central portion of the lesion in a scaffold-treated primate, showing reduced gliosis compared to
controls restricted to lesion border.
Glial Scarring and Astrogliosis Glial Fibrillary Acidic Protein (GFAP) Immunolabeling
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‘09 Data Confirm ‘08 Pilot Primate Data
Principal Component Analysis (PCA) Individual Data
Principal component analysis (PCA; see Courtine, G., et al., Nat Neurosci 12:1333-1342, 2009) was applied to 149 quantified kinematic, EMG and gait parameters. Resulting PCA scores were used to compare treatment groups. The dashed line represents the average pre-lesion PCA scores. Higher PCA scores signify greater recovery.
Typical representation of individual kinematic, EMG, and gait
parameters from a single primate.
Av
era
ge
PC
A S
co
re
Control Scaffold0
5
10
15
(n=3)
(n=4)
Week 12
Treatment Group
from Nature Neuroscience
Symbol: NVIV
Replication by Academic Researchers
Symbol: NVIV
Anticipated FDA Clinical Study
• Human Pilot Study • 2nd Half of 2012 • Positive FDA Meeting held on April 12, 2012
• FDA Affirmed HDE regulatory pathway –will expedite approval
• Acute SCI patients with contusion injuries • Open label study-will report on results as patients are treated
• Clinical Sites: • Harvard Brigham & Women’s in Boston • Geisinger Health System in Pennsylvania
• Rehabilitation: The Shepherd Center, Atlanta • One year follow-up
• Human Pivotal Study • To be conducted if requested • 30 acute contusion SCI patients
Symbol: NVIV
IP & Manufacturing
Exclusive, world-wide license from Children’s Medical Center Corporation and MIT
• Covers the use of a wide range of biopolymers to treat SCI, and to promote the survival and proliferation of human stem cells in the spinal cord.
• 11 issued and 4 pending US patents
• 57 issued and 34 international pending patents
Opened new manufacturing and development facility to support first human clinical trial
• Raw materials for first device product readily available from FDA-cleared suppliers
• Proprietary manufacturing processes will include 46 3D printing and batch processes to create the scaffolds.
Symbol: NVIV
Go-To-Market Strategy
• Ease of market penetration – 80% of SCIs treated in only 75 Level I Trauma Centers in USA
• No need to strategically license to reach our market
• Forecasted price $60,000/unit – Could exceed $100,000+/unit
• Direct sales force: ~20 for entire USA
• Fast early adoption by spine surgeons
• Complements current standard of care with one surgery
• In-house manufacturing of FDA-approved materials
• Results in gross margins ~85+%
Symbol: NVIV
Market Stats
Trading Symbol NVIV
Stock Price* $2.20
Exchange OTC. BB
Market Cap* $141.5 M
Primary Shares Outstanding 64.3M
Fully Diluted Shares 89.6M
Approx. Float 42.0M
Avg. Daily Trading Volume 265,000 shares
Inside Ownership 37%
52 Week Range $0.60-$3.23
Cash on Hand at 3.31.12 $20.5M
Burn Rate $855,000/month
* Information as of June 6, 2012
Symbol: NVIV
Market Stats
Symbol: NVIV
Cost Effective Business Model
$929
$338
$107
$36
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StemCells, Inc
NeuralStem,Inc
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Symbol: NVIV
Milestones
Finalized Plan with FDA for Human Study in 2012
Raised $20 M in public offering with blue chip institutions
2011 Apple Award from American Spinal Injury Assoc.
Expanded Patent to Peripheral Nerves, Prostate, Retina, and Brain
• Determine regulatory pathway for hydrogel + steroidal drug: Q2 2012
• File IDE for Peripheral Nerve Injection: Q3 2012
• Complete Pre-Clinical Sloan Kettering Prostate Study Q3 2012
• Begin Patient Enrollment for scaffold: 2nd Half 2012
Symbol: NVIV
Summary Near-Term Value Creating Milestones Will Drive Shareholder Value
– Pilot human trial approval and human clinical data in late 2012 – Second Product based on our hydrogel to be filed with FDA in 2012 – Potential for revenue generation by end of 2013
Acute SCI Represents a $10+ Billon Untapped Market Opportunity
– No products today will effectively treat a spinal cord injury Efficient Go-to -Market Strategy Generates High Profits for InVivo Shareholders
– 80% of SCI patients are treated at the top 75 Level One Trauma Centers – Small sales force of ~20 will provide sales coverage for the US Market. – Gross margins approaching 85%
InVivo Has a Robust Platform Technology and Product Pipeline
– Exclusive Worldwide Patent Licensed from MIT and Harvard – Injectable hydrogel: time released drug delivery for back pain, prostate nerve, SCI – Biopolymer scaffoldings seeded with cellular therapies to treat chronic SCI
“NVIV” with a $144 Million Market Cap has Significant Upside Potential
– Acorda -$938 million market cap, VeraStem Pre-IND $210M
Symbol: NVIV
InVivo Therapeutics Holdings Corp.
Stock Symbol: NVIV.OB